In Vitro Comparison of Four Cerebral Protection Filters for Preventing Human Plaque Embolization during Carotid Interventions

Abstract

Purpose:

To evaluate in an in vitro bench-top model the efficacy of 4 filtration devices designed for cerebral protection during carotid angioplasty.

Methods:

Embolization during carotid angioplasty was simulated with human plaque material (8 to 12 particles weighing 6.02 ± 0.10 mg) in an open flow model with the aortic arch and carotid bifurcation made from elastic silicone tubes and saline used as the fluid medium. The 500 to 1500-µm particles were injected into the internal carotid artery (ICA) in front of the test protection device, which was deployed 5 cm distal to the bifurcation. Particles getting past the protection device or flowing into the external carotid artery (ECA) were caught in 100-µm filters and weighed. Ten trials were made on each of 4 devices: Angioguard, FilterWire EX, TRAP, and NeuroShield. All were deployed according to the manufacturers' directions except the FilterWire, which was manually repositioned in all tests to eliminate a gap between the filter and the tube wall.

Results:

The lowest weight of missed particles in the effluent was obtained with the NeuroShield (0.05 ± 0.04 mg, 0.8% of injected particle weight) and FilterWire (0.08 ± 0.05 mg, 1.3%; p=0.254 compared to NeuroShield, p=0.006 versus TRAP). The weight of particles missed by the TRAP device (0.16 ± 0.06 mg, 2.6%; p<0.001 versus NeuroShield and Angioguard, p<0.05 compared to Filter Wire) was higher, and the largest amount of missed particles was observed with the Angioguard filter (0.27 ± 0.06 mg, 4.4%; p<0.001 compared to all). NeuroShield and FilterWire were significantly different (p<0.001) compared to Angioguard and TRAP in a pairwise analysis. No embolization into the ECA occurred.

Conclusions:

In vitro, none of the tested devices had the ability to completely prevent embolization into the ICA. Comparing current designs, the NeuroShield filter and the FilterWire EX captured the highest percentage of human particles in this in vitro model, probably due to their larger filter volume.

Keywords

carotid arteries carotid angioplasty embolism bench-top model

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References

Phatouros

Higashida

Malek

. Carotid artery stent placement for atherosclerotic disease: rationale, technique, and current status. Radiology. 2000;217:26–41.

Ferguson

Eliasziw

Barr

. The North American Symptomatic Carotid Endarterectomy Trial: surgical results in 1415 patients. Stroke. 1999;30:1751–1758.

European Carotid Surgery Trialists' Collaborative Group. MRC European Carotid Surgery Trial: interim results for symptomatic patients with severe (70–99%) or with mild (0–29%) carotid stenosis. Lancet. 1991;337:1235–1243.

Asymptomatic Carotid Atherosclerosis Study. Clinical advisory: carotid endarterectomy for patients with asymptomatic internal carotid artery stenosis. Stroke. 1994;25;2523–2524.

Diethrich

Ndiaye

Reid

. Stenting in the carotid artery: initial experience in 110 patients. J Endovasc Surg. 1996;3:42–62.

Henry

Amor

Klonaris

. Angioplasty and stenting of the extracranial carotid arteries. Tex Heart Inst J. 2000;27:150–158.

Yadav

Roubin

Iyer

. Elective stenting of the extracranial carotid arteries. Circulation. 1997;95:376–381.

Macdonald

McKevitt

Venables

. Neurological outcomes after carotid stenting protected with the NeuroShield Filter compared to unprotected stenting. J Endovasc Ther. 2002;9:000–000.

Théron

Raymond

Casasco

. Percutaneous angioplasty of atherosclerotic and postsurgical stenosis of carotid arteries. AJNR Am J Neuroradiol. 1987;8:495–500.

10.

Théron

Courtheoux

Alachkar

. New triple coaxial catheter system for carotid angioplasty with cerebral protection. AJNR Am J Neuroradiol. 1990;11:869–874.

11.

Théron

Payelle

Coskun

. Carotid artery stenosis: treatment with protected balloon angioplasty and stent placement. Radiology. 1996;201:627–636.

12.

Parodi

La Mura

Ferreira

. Initial evaluation of carotid angioplasty and stenting with three different cerebral protection devices. J Vasc Surg. 2000;32:1127–1136.

13.

Schluter

Tubler

Mathey

. Feasibility and efficacy of balloon-based neuroprotection during carotid artery stenting in a single-center setting. J Am Coll Cardiol. 2002;40:890–895.

14.

Al-Mubarak

Colombo

Gaines

. Multicenter evaluation of carotid artery stenting with a filter protection system. J Am Coll Cardiol. 2002;39:841–846.

15.

Adami

Scuro

Spinamano

. Use of the Parodi Anti Embolism System in carotid stenting: Italian trial results. J Endovasc Ther. 2002;9:147–154.

16.

Henry

Amor

Henry

. Carotid stenting with cerebral protection: first clinical experience using the PercuSurge GuardWire system. J Endovasc Surg. 1999;6:321–331.

17.

Henry

Klonaris

. Benefits of cerebral protection during carotid stenting with the PercuSurge GuardWire System: midterm results. J Endovasc Ther. 2002;9:1–13.

18.

Reimers

Corvaja

Moshiri

. Cerebral protection with filter devices during carotid artery stenting. Circulation. 2001;104:12–15.

19.

Cremonesi

Castriota

. Efficacy of a nitinol filter device in the prevention of embolic events during carotid interventions. J Endovasc Ther. 2002;9:155–159.

20.

Albuquerque

Teitelbaum

Lavine

. Balloon-protected carotid angioplasty. Neurosurgery. 2000;46:918–923.

21.

Müller-Hülsbeck

Grimm

Liess

. Comparison and modification of two cerebral protection devices used for carotid angioplasty: in vitro experiment. Radiology. 2002;225:289–294.

22.

Jaeger

Mathias

Drescher

. Clinical results of cerebral protection with a filter device during stent implantation of the carotid artery. Cardiovasc Intervent Radiol. 2001;24:249–256.

23.

Tübler

Schlüter

Dirsch

. Balloon-protected carotid artery stenting: relationship of periprocedural neurological complications with the size of particulate debris. Circulation. 2001;104:2791–2796.

24.

Grego

Frigatti

Amista

. Prospective comparative study of two cerebral protection devices in carotid angioplasty and stenting. J Cardiovsc Surg. 2002;43:391–397.

25.

Whitlow

Lylyk

Londero

. Carotid artery stenting protected with an emboli containment system. Stroke. 2002;33:1308–1314.

26.

Macdonald

Venables

Cleveland

. Protected carotid stenting: safety and efficacy of the MedNova NeuroShield filter. J Vasc Surg. 2002;35:966–972.

27.

Müller-Hülsbeck

Jahnke

Liess

. Comparison of various cerebral protection devices for carotid angioplasty: an in-vitro experiment. J Vasc Interv Radiol. 2003; in print.

28.

Crawley

Clifton

Buchenham

. Comparison of hemodynamic cerebral ischemia and microembolic signals detected during carotid endarterectomy and carotid angioplasty. Stroke. 1997;28:2460–2464.

29.

Jaeger

Mathias

Hauth

. Cerebral ischemia detected with diffusion-weighted MR imaging after stent implantation in the carotid artery. AJNR Am J Neuroradiol. 2002;23:200–207.

30.

Coggia

Goeau-Brissonniere

Duval

. Embolic risk of the different stages of carotid bifurcation balloon angioplasty: an experimental study. J Vasc Surg. 2000;31:550–557.

31.

Bladin

Bingham

Grigg

. Transcranial Doppler detection of microemboli during percutaneous transluminal coronary angioplasty. Stroke. 1998;29:2367–2370.

32.

Ohki

Roubin

Veith

. Efficacy of a filter device in the prevention of embolic events during carotid angioplasty and stenting: an ex vivo analysis. J Vasc Surg. 1999;30:1034–1044.

33.

Théron

Guimarens

Coskun

. Complications of carotid angioplasty and stenting. Neurosurg Focus. 1998;5:1–19.

34.

Mathis

Barr

Jungreis

. Temporary balloon test occlusion of the internal carotid artery: experience in 500 cases. AJNR Am J Neuroradiol. 1995;16:749–754.